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NCT Number: NCT02421770

Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treat Oral Lichen Planus

Oral lichen planus (OLP) is a chronic inflammatory mucocutaneous disease characterized by outbreaks or flares. It affects 0.2-1.9% of the population. Although the etiology is unknown, the pathogenesis of OLP is known to involve an immune disorder, with epithelial damage caused by cytotoxic CD8 + lymphocytes. Clinically, the disease is characterized by different types of lesions - papular, reticular and in the form of plaques - that can alternate with erosive and/or ulcerative areas. A variety of treatments have been proposed for OLP: topical or systemic corticosteroids, cyclosporine, retinoids, azathioprine, tacrolimus, pimecrolimus, photochemotherapy and surgery. Patients with symptomatic OLP often require intensive therapy to reduce the signs and symptoms. The disease can produce considerable morbidity and alter patient quality of life, particularly in the presence of ulcerative lesions.

There is no fully resolutive and effective treatment - the management strategy focusing on the use of drugs that counter tissue inflammation and the underlying immunological mechanisms. The main inconvenience of these treatments is represented by the side effects they usually produce.

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pia Lopez Jornet

Murcia, 30008, Spain

About this study

The purpose of this study was to evaluate that if Chamaemelum Nobile a can be used in the treatment of oral lichen planus. This could be useful as Chamaemelum Nobile has no reported side effects and hence it can used in place of steroids which are commonly used for this condition and have many reported adverse effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients clinically & histopathologically diagnosed to be suffering from oral lichen planus.
  • Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen planus.
  • Patients not on any treatment for the same. In case they were, then such treatment was stopped and a washout period of two weeks was given.

Exclusion criteria

  • Patients suffering from any systemic disease/s like
  • Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
  • Patients on any drug therapy which may cause lichen planus like lesions.
  • Patients with findings of any physical or mental abnormality, which would interfere with or be affected by the study procedure.
  • Patients with a known allergy or contraindication to study medications

Treatment and study plan

Chamaemelum nobile 2%

Other

Experimental Chamaemelum Nobile 2% gel Active "During the 6-week double-blind phase, all patients will be randomly assigned to receive Chamaemelum Nobile 2% gel Active or its vehicle twice daily with occlusion on the affected are

Placebo

Other

Primary outcomes

  1. Relief from signs & symptoms of disease (Visual Analog Scale and change in size of target lesion)

    Time frame: 6 week

    The primary study end-point was the Visual Analog Scale (VAS) score for pain change in the size of the target erosion, erythema at the start and after 6week

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Chamaemelum Nobile 2% Versus Placebo Topic Gel to Treatment Oral LichenPlanus

Acronym: lichenPlanus

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2015
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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